The effect of non-steroidal anti-inflammatory drugs on bleeding, platelet function and consumption of opiates following cardiac surgery

ISRCTN ISRCTN14974395
DOI https://doi.org/10.1186/ISRCTN14974395
Secondary identifying numbers 0120-430/2016-2
Submission date
07/04/2018
Registration date
25/04/2018
Last edited
30/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
The pain following heart surgery is mostly associated with sternotomy (surgical procedure to divide the sternum), pericardiectomy (removal of the membrane around the heart), chest tube insertion, and the removal of a vein from a patient's leg. Traditionally, intravenous opioids are used for pain management after heart surgery.
However, their use is associated with side effects, such as nausea, vomiting, itching, urinary
retention, intestinal paresis, and respiratory depression. Long-acting opioids administered after surgery postpone the removal of the ventilation tube in the windpipe (extubation) due to increased sedation and respiratory depression (inadequate slow and shallow breathing).
A combination of nonsteroidal anti-inflammatory drugs (NSAID) and opioid analgetics has been recommended for pain relief after major surgeries. The need of opioid analgesics can be reduced by using NSAIDs, thus also reducing the side effects of opioid analgesics, especially nausea and vomiting. The combination of NSAID and opioid analgesics contributes to an earlier extubation and patient mobilisation leading to an early discarge from the ICU.
The aim of the study is to confirm whether NSAID diclofenac decreases the use of opioid analgesics following cardiac surgery during the first 20 hours after surgery.

Who can participate?
Adults aged 20 – 85 years undergoing elective cardiac surgery

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive intravenous Diclofenac after cardiac surgery, whilst those in the control group receive intravenous saline. Participants are followed up for 20 hours after surgery.

What are the possible benefits and risks of participating?
There are no specific benefits or risks for those taking part in the study.

Where is the study run from?
University Medical Centre Maribor (Slovenia)

When is the study starting and how long is it expected to run for?
May 2016 to December 2018

Who is funding the study?
University Medical Centre Maribor (Slovenia)

Who is the main contact?
Mrs Irena Osojnik (Scientific)
irena.ogrizek@guest.arnes.si

Contact information

Mrs Irena Osojnik
Scientific

University Medical Centre Maribor
Ljubljanska ulica 5
Maribor
2000
Slovenia

Phone + 386 51 243 260
Email irena.ogrizek@guest.arnes.si

Study information

Study designSingle-centre prospective randomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of diclofenac on bleeding, platelet function, and the use of opiates following coronary artery bypass graft
Study objectivesThe purpose of the study is to establish whether using diclofenac after a coronary artery bypass graft (CABG) with extracorporeal circuit decreases the consumption of opioid analgesics and their side effects. It also aims to establish whether diclofenac disrupts the platelet function and consequently increases bleeding and transfusion of blood and blood products after cardiac surgery.
Ethics approval(s)1. Commission of the Republic of Slovenia for Medical Ethics (Komisija Republike Slovenije za medicinsko etiko), 22/08/16, ref: 0120-430
2. Republic of Slovenia National Medical Ethics Committee (NMEC) 10/08/2016, ref: 2016-2
Health condition(s) or problem(s) studiedCardiac surgery
InterventionAfter cardiac surgery, participants are randomised to one of two treatment groups using coin randomisation.
1. The treatment group receive an intravenous infusion of 75 mg diclofenac (250 ml Neodolpasse) within 90 minutes to three hours after cardiac surgery, and again after 12 hours.
2. The control group receive an infusion of 250 ml of saline (0.9% NaCl) within 90 minutes to three hours after surgery, and again after 12 hours.

Both groups are followed up 20 hours after surgery.
Both groups receive intravenous bolus piritramid 0.05 mg/kg body weight every six hours for postoperative pain relief. In addition to basal pain relief the patients receive additional piritramid 0.025 mg/kg on request by means of nurse controlled analgesia to achieve adequate analgesia (NRS ≤ 3).
Intervention typeDrug
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)Diclofenac
Primary outcome measure1. Pain is measured using the NRS (numerical rating scale) for pain assessment at 1 hour intervals until 20 hours after surgery
2. The use of piritramide is recorded within the first 20 hours after surgery
3. The use of blood and blood product is recorded within the first 20 hours after surgery
Secondary outcome measures1. Heamodynamic data (invasive blood pressure and heart rate) is measured using Phillips MX 800 monitor at 1 hour intervals until 20 hours after surgery
2. Sternal drain blood loss is measured using Sternal drainage system Atrium at 1 hour intervals until 20 hours after surgery
3. Time to extubation and time of ICU stay is recorded.
4. Unfavourable side effects are recorded during the ICU stay
Overall study start date01/05/2016
Completion date30/12/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60
Total final enrolment72
Key inclusion criteria1. Adult aged 20 - 85 years
2. Operated for elective cardiac surgery using extracorporeal circuit
Key exclusion criteria1. History of peptic ulcer disease, gastointestinal bleeding
2. Renal and liver insufficiency
3. Allergy for nonsteroidal analgetics
4. Increased bleeding during surgery
5. Increased bleeding after surgery, as defined by the chest tube drainage of more than 300 ml per hour during the first 3 hours after surgery.
Date of first enrolment30/10/2016
Date of final enrolment30/08/2018

Locations

Countries of recruitment

  • Slovenia

Study participating centre

University Medical Centre Maribor
Maribor
+386 51 243 260
Slovenia

Sponsor information

University Medical Centre Maribor
Hospital/treatment centre

Medical Research Department
Ljubljanska ulica 5
Maribor
2000
Slovenia

Phone +386 321 1000
Email irena.osojnik@ukc-mb.si
ROR logo "ROR" https://ror.org/02rjj7s91

Funders

Funder type

Hospital/treatment centre

University Medical Centre Maribor

No information available

Results and Publications

Intention to publish date30/06/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication of results in Medical Journals.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request.

Additional documents are available upon request from the author.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 07/11/2019 30/03/2020 Yes No

Editorial Notes

30/03/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.